Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

GE OEC Medical Systems, its parent company, General Electric -- doing business as GE Healthcare -- and two of their top executives have signed a consent decree of permanent injunction related to X-ray surgical imaging systems, the FDA announced.

The decree was filed Jan. 12 in the U.S. District Court for the District of
Utah and is subject to court approval.

The decree "prohibits the manufacturing and distribution of specified
GE OEC Medical Systems X-ray surgical imaging systems" at facilities in
Salt Lake City, Utah, and Lawrence, Mass., "until the devices and facilities
have been shown to be in compliance" with the FDA's current good manufacturing
practice (cGMP) requirements as set forth in the quality system regulation for
devices, the agency said.